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Can special glasses or eyedrops stop kids' eyesight from getting worse?

NCT ID NCT07095894

Disease control Sponsor: Jaeb Center for Health Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests two treatments to slow the progression of myopia (nearsightedness) in children aged 5 to 12. One treatment uses special glasses with tiny lenslets that may reduce eye growth, and the other uses low-dose atropine eyedrops. Over 300 children will be followed for 2 years to see if these treatments slow the worsening of their vision better than standard glasses or placebo drops.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
0.05% atropine eyedrops and spectacle lenses with highly aspherical lenslets (H.A.L.T.)
What this could lead to
If successful, this could provide a safe, non-surgical way to slow worsening nearsightedness in children, reducing the need for stronger prescriptions and lowering future eye health risks.
What could go wrong
This is a Phase 3 trial, but results from earlier studies have been mixed, especially in non-Asian children. The treatments may not work as well in this broader group, and atropine can cause side effects like light sensitivity or blurry near vision.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 348 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 11 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 5 years to \<12 years at time of enrollment. Children within 4 weeks of their 12th birthday are not eligible. 2. Refractive error meeting the following by cycloplegic autorefraction: * Myopia of 0.75D to 6.00D SER and at least 0.75D in both principal meridians of each eye * Astigmatism \<2.50D both eyes * Anisometropia \<1.50D SER 3. Investigator has confirmed the following regarding best-corrected distance visual acuity (VA) in habitual spectacles or trial frames using the investigator's preferred VA testing method: * VA is age normal in both eyes1,2 * 5-6 years: approximately 20/32 or better, ≤ 0.24 logMAR, ≥ 73 letters * 7-12 years: approximately 20/25 or better, ≤ 0.14 logMAR, ≥ 78 letters * Interocular difference ≤2 logMAR lines (0.2 logMAR) or ≤ 10 letters 4. Wearing spectacles by parent report ≥90% of waking hours ≥30 days duration before enrollment. For children who meet all other inclusion criteria but whose single-vision spectacles are broken or lost within the last 90 days, enrollment can proceed as long as the child was wearing their single-vision spectacles ≥90% of waking hours ≥30 days before the spectacles were broken or lost. 5. Gestational age ≥ 32 weeks. 6. Birth weight \>1500 g. 7. Parent(s) and assenting child understand the study procedures and are willing to accept randomization to atropine 0.05%, HAL lenses, atropine combined with HAL lenses, or placebo (i.e., neither active treatment). 8. Parent is willing to participate in a 2- to 4-week run-in phase using nightly artificial tear eyedrops in both eyes. 9. Family can return in 2 to 4 weeks for possible randomization. 10. Child is willing to refrain from contact lenses for the duration of the study. 11. Parent has a phone (or access to a phone) and is willing to be contacted by the clinical site staff. 12. Relocation outside of the area of an active PEDIG site within the next 32 months is not anticipated. Exclusion Criteria: 1. Current or previous pharmacologic or light therapy used for myopia treatment. 2. Current or prior contact lens wear more than 7 days in the past 12 months 3. Current or previous use of bifocals, progressive-addition lenses, multi-focal contact lenses, or focus- or contrast-modifying spectacle lenses. 4. Current or previous use of orthokeratology, rigid gas permeable, or other contact lenses used to slow myopia progression. 5. Current or previous myopia control treatment or other uses of atropine, pirenzepine or other anti-muscarinic agents. 6. Known atropine allergy 7. Known allergy to shellfish 8. Abnormality of the cornea, lens, central retina, iris, or ciliary body 9. Current constant or intermittent strabismus (phorias are acceptable) 10. Verified history of amblyopia or nystagmus. 11. Prior strabismus, intraocular, or refractive surgery 12. Down syndrome or cerebral palsy 13. Diseases known to affect accommodation, vergence, or ocular motility (e.g., multiple sclerosis, Graves' disease, myasthenia gravis, diabetes mellitus) 14. Any condition that, in the judgment of the investigator, could influence refractive error development. 15. Existing conditions in the opinion of the investigator that may affect the long-term health of the eye or require regular pharmacologic treatment that may adversely interact with study medication (e.g., JIA, glaucoma, pre-diabetes). 16. Inability to comprehend and/or perform any study-related procedures. 17. Individuals who are pregnant, lactating, or intending to become pregnant within the next 30 months. a. A negative urine pregnancy test at randomization and the 6-, 12-, 18-, and 24-month follow-up visits will be required for individuals who have experienced menarche (at least one menstrual cycle). 18. Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is investigative site personnel directly affiliated with this study or who is an employee of the Jaeb Center for Health Research. 19. Sibling of, or living in the same household as, another child who is concurrently enrolled in the study.

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Conditions

The condition(s) this trial relates to.

myopia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myopia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Boston Children's Hospital Waltham

    RECRUITING

    Boston, Massachusetts, 02453, United States

  • Casey Eye Institute

    RECRUITING

    Portland, Oregon, 97239, United States

  • Corewell Health

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Duke University Eye Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Illinois College of Optometry

    RECRUITING

    Chicago, Illinois, 60616, United States

  • Marshall B. Ketchum University

    RECRUITING

    Fullerton, California, 92831, United States

  • Ohio State University College of Optometry

    RECRUITING

    Columbus, Ohio, 43210-1280, United States

  • Pediatric Ophthalmology Associates, Inc.

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Pennsylvania College of Optometry, Salus at Drexel University

    RECRUITING

    Philadelphia, Pennsylvania, 19141, United States

  • Rocky Mountain Eye Care Associates

    RECRUITING

    Salt Lake City, Utah, 84107, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94303, United States

  • UAB Pediatric Eye Care; Birmingham Health Care

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Arizona

    RECRUITING

    Tucson, Arizona, 85711, United States

  • University of Houston - College of Optometry

    RECRUITING

    Houston, Texas, 77204, United States

  • Vanderbilt University Medical Center - Vanderbilt Eye Institute

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Virginia Pediatric Eye Center

    RECRUITING

    Norfolk, Virginia, 23502, United States

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